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NCT04194398 · ClinicalTrials.gov registry record

OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection

A clinical trial of OCS Lung System, sponsored by TransMedics.

Completed
Registry status
79
Enrollment target
8
Study locations

NCT04194398: Completed study of OCS Lung System, sponsored by TransMedics.

NCT04194398 is a study of OCS Lung System that has completed, run by TransMedics. The registered enrollment target is 79 participants. The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04194398, a study of OCS Lung System, has completed, sponsored by TransMedics.

COMPLETED
Registry status
79 participants
Enrollment target
8
Study locations

Study Summary

Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.

Primary Outcome

Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.

Conditions Studied

Interventions

  • DEVICE OCS Lung System

Study Locations (8)

California

  • University of California at Los Angeles - Los Angeles
  • University of California at San Francisco - San Francisco

Other

  • Hospitals Leuven - Leuven
  • Hannover Medical School - Hanover

Arizona

  • St. Joseph's Hospital and Medical Center - Phoenix

Massachusetts

  • Massachusetts General Hospital - Boston

Minnesota

  • University of Minnesota - Minneapolis

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2018-12-31
Est. Completion 2021-09-30
TransMedics

23 total trials

What the finished NCT04194398 record still lists

NCT04194398 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 79 participants, a relatively small participant target.

The record links to 1 condition, with OCS Lung System appearing as the primary indexed condition, and to 1 intervention - of which OCS Lung System is the first listed.

NCT04194398 lists 8 locations in 6 states (California, Other, Arizona).

Frequently Asked Questions

What is clinical trial NCT04194398 about?

NCT04194398 is a clinical study titled "OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection". Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.

What is the current status of trial NCT04194398?

This trial is currently completed. The enrollment target is 79 participants. The study started on 2018-12-31. Estimated completion is 2021-09-30.

What conditions does trial NCT04194398 study?

This clinical trial studies the following conditions: OCS Lung System.

What interventions are being tested in trial NCT04194398?

The interventions under investigation include: OCS Lung System (DEVICE).

Who is sponsoring clinical trial NCT04194398?

This trial is sponsored by TransMedics, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04194398 being conducted?

This trial has 8 study locations across Arizona, California, Massachusetts, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04194398, the US trial registry maintained by the National Library of Medicine. NCT04194398 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.